Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Cochlear Implantation
Policy #:MA11.039d

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

MEDICALLY NECESSARY

Cochlear implantation is considered medically necessary and, therefore, covered for individuals with a documented diagnosis of bilateral pre- or post-linguistic moderate-to-profound sensorineural hearing impairment when all of the following criteria are met:
  • The individual demonstrates limited benefit from hearing (or vibrotactile) aids.
    • Limited benefit from amplification is defined by test scores of less than or equal to 40 percent correct on tape-recorded tests of open-set sentence cognition in the best-aided listening condition.
  • The individual has the cognitive ability to use auditory clues and a willingness to undergo an extended program of rehabilitation.
  • The cochlear lumen is accessible, structurally suited to implantation, free of middle ear infection, and free of lesions in the auditory nerve and acoustic areas of the central nervous system.
  • A cochlear implant must be used in accordance with the labeling approved by the FDA.
  • The individual has no contraindications to surgery

Cochlear implantation with a hybrid cochlear implant/hearing aid device that includes the hearing aid integrated into the external sound processor of the cochlear implant (e.g., the Nucleus® Hybrid™ L24 Cochlear Implant System) is considered medically necessary and, therefore, covered when all of the following criteria are) met:
  • Individual is 18 years and older
  • Individual has bilateral severe-to-profound high-frequency sensorineural hearing loss with residual low-frequency hearing sensitivity;
  • Individual received limited benefit from appropriately fit bilateral hearing aids;
  • Individual has the following hearing thresholds:
    • Low-frequency hearing thresholds no poorer than 60 dB hearing level up to and including 500 Hz (averaged over 125, 250, and 500 Hz) in the ear selected for implantation; AND
    • Severe to profound mid- to high-frequency hearing loss (threshold average of 2000, 3000, and 4000 Hz ≥75 dB hearing level) in the ear to be implanted; AND
    • Moderately severe to profound mid- to high-frequency hearing loss (threshold average of 2000, 3000, and 4000 Hz ≥60 dB hearing level) in the contralateral ear; AND
    • Aided consonant-nucleus-consonant word recognition score from 10% to 60% in the ear to be implanted in the preoperative aided condition and in the contralateral ear will be equal to or better than cthat of the ear to be implanted but not more than 80% correct.

Cochlear implantation as a treatment for unilateral hearing loss with or without tinnitus is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

INVESTIGATIONAL DEVICE EXEMPTION (IDE)
In addition, cochlear implantation may be covered for individuals meeting the above criteria and with hearing test scores of greater than 40% and less or equal to 60% only when the provider is participating in, and the individual is enrolled in, either an FDA-approved category B investigational device exemption (IDE) clinical trial or a prospective, controlled comparative trial approved by the Centers for Medicare and Medicaid Services (CMS), as consistent with the evidentiary requirements for National Coverage Analyses and meeting specific quality standards.

NONCOVERED

An assistive listening device for use with a cochlear implant (e.g., telephone microphone) is not covered by the Company because it is an item not covered by Medicare. Therefore, it is not eligible for reimbursement consideration.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Policy Guidelines

This policy is consistent with Medicare's coverage criteria. The Company's payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, cochlear implantation (unilateral and bilateral) is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met. However, services that are identified in this policy as noncovered are not eligible for coverage or reimbursement by the Company.

Subject to the applicable Evidence of Coverage, an assistive listening device for use with a cochlear implant is not eligible for payment under the medical benefits of the Company’s Medicare Advantage products because the service is considered not covered.

Services that are experimental/investigational are excluded from the Company's Medicare Advantage products. Therefore, they are not eligible for reimbursement consideration.

Description

A cochlear implant device is an electronic instrument, part of which is implanted surgically to stimulate auditory nerve fibers, and part of which is worn or carried by the individual to capture, analyze, and code sound. Cochlear implant devices are available in single-channel and multi-channel models. The purpose of implanting the device is to provide awareness and identification of sounds and to facilitate communication for persons who are moderately to profoundly hearing impaired.

A cochlear implant with a hybrid cochlear implant/hearing aid device includes the hearing aid integrated into the external sound processor of the cochlear implant. It is indicated for unilateral use in individuals aged 18 years and older who have severe to profound mid- and high-frequency sensorineural hearing loss and normal to moderate low-frequency hearing loss, and who obtain limited benefit from an appropriately fit bilateral hearing aid.
References

Centers for Medicare & Medicaid Services (CMS). Decision Memo for Cochlear Implantation (CAG-00107N). [CMS Web site]. 04/04/2005. Available at:
https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=134. Accessed June 18, 2018.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 50.3: Cochlear implantation. [CMS Web site]. Original: 04/04/05. Available
at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=245&ncdver=2&bc=BAABAAAAAAAA&. Accessed June 18, 2018.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 310.1 Routine Costs of Clinical Trials. 07/09/2007. [CMS Web site]. Available at :
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1&ncdver=2&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=routine&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAABAAAAAA&. Accessed June 18, 2018.

ClinicalTrials.gov. Evaluation of revised indicatons (ERID) for cochlear implant candidacy for the adult CMS population [Clinical Trials.gov Web site]. 05/25/2018 Available at: https://clinicaltrials.gov/ct2/show/NCT02075229. Accessed June 18, 2018.

Lenarz T, James C, Cuda D, et al. European multi-centre study of the Nucleus Hybrid L24 cochlear implant. Int J Audiol. 2013;52(12):838-848.

Roland JT, Jr., Gantz BJ, Waltzman SB, et al. United States multicenter clinical trial of the cochlear nucleus hybrid implant system. Laryngoscope. 2016;126(1):175-181.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Cochlear Implants. Premarket approval database. [FDA Web site]. 06/18/2018. Available at:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. Accessed June 18, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Devices@FDA. Cochlear Implant [FDA Web site]. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/CochlearImplants/ucm062882.htm. Accessed June 18, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Nucleus Hybrid L24 Cochlear Implant System -- P130016. Premarket approval letter. [FDA Web site]. 03/20/14. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130016a.pdf. Accessed June 18, 2018.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

69930, 92601, 92602, 92603, 92604, 92626, 92627, 92630, 92633


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

MEDICALLY NECESSARY

H90.A21 Sensorineural hearing loss, unilateral, right ear, with restricted hearing on the contralateral side

H90.A22 Sensorineural hearing loss, unilateral, left ear, with restricted hearing on the contralateral side

H90.A31 Mixed conductive and sensorineural hearing loss, unilateral, right ear with restricted hearing on the contralateral side

H90.A32 Mixed conductive and sensorineural hearing loss, unilateral, left ear with restricted hearing on the contralateral side

H90.3 Sensorineural hearing loss, bilateral

H90.6 Mixed conductive and sensorineural hearing loss, bilateral

T85.618A Breakdown (mechanical) of other specified internal prosthetic devices, implants and grafts, initial encounter

T85.618D Breakdown (mechanical) of other specified internal prosthetic devices, implants and grafts, subsequent encounter

T85.618S Breakdown (mechanical) of other specified internal prosthetic devices, implants and grafts, sequela

T85.628A Displacement of other specified internal prosthetic devices, implants and grafts, initial encounter

T85.628D Displacement of other specified internal prosthetic devices, implants and grafts, subsequent encounter

T85.628S Displacement of other specified internal prosthetic devices, implants and grafts, sequela

T85.638A Leakage of other specified internal prosthetic devices, implants and grafts, initial encounter

T85.638D Leakage of other specified internal prosthetic devices, implants and grafts, subsequent encounter

T85.638S Leakage of other specified internal prosthetic devices, implants and grafts, sequela

T85.698A Other mechanical complication of other specified internal prosthetic devices, implants and grafts, initial encounter

T85.698D Other mechanical complication of other specified internal prosthetic devices, implants and grafts, subsequent encounter

T85.698S Other mechanical complication of other specified internal prosthetic devices, implants and grafts, sequela

Z45.321 Encounter for adjustment and management of cochlear device

Z45.328 Encounter for adjustment and management of other implanted hearing device

Z45.49 Encounter for adjustment and management of other implanted nervous system device

Z46.2 Encounter for fitting and adjustment of other devices related to nervous system and special senses

Z51.89 Encounter for other specified aftercare


EXPERIMENTAL/INVESTIGATIONAL

H90.A11 Conductive hearing loss, unilateral, right ear with restricted hearing on the contralateral side

H90.A12 Conductive hearing loss, unilateral, left ear with restricted hearing on the contralateral side

H90.11 Conductive hearing loss, unilateral, right ear, with unrestricted hearing on the contralateral side

H90.12 Conductive hearing loss, unilateral, left ear, with unrestricted hearing on the contralateral side

H90.41 Sensorineural hearing loss, unilateral, right ear, with unrestricted hearing on the contralateral side

H90.42 Sensorineural hearing loss, unilateral, left ear, with unrestricted hearing on the contralateral side

H90.71 Mixed conductive and sensorineural hearing loss, unilateral, right ear, with unrestricted hearing on the contralateral side

H90.72 Mixed conductive and sensorineural hearing loss, unilateral, left ear, with unrestricted hearing on the contralateral side



HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

L8614 Cochlear device, includes all internal and external components

L8615 Headset/headpiece for use with cochlear implant device, replacement

L8616 Microphone for use with cochlear implant device, replacement

L8617 Transmitting coil for use with cochlear implant device, replacement

L8618 Transmitter cable for use with cochlear implant device or auditory osseointegrated device, replacement

L8619 Cochlear implant, external speech processor and controller, integrated system, replacement

L8621 Zinc air battery for use with cochlear implant device, replacement, each

L8622 Alkaline battery for use with cochlear implant device, any size, replacement

L8623 Lithium ion battery for use with cochlear implant device speech processor, other than ear level, replacement, each

L8624 Lithium ion battery for use with cochlear implant or auditory osseointegrated device speech processor, ear level, replacement, each

L8625 External recharging system for battery for use with cochlear implant or auditory osseointegrated device, replacement only, each

L8627 Cochlear implant, external speech processor, component, replacement

L8628 Cochlear implant, external controller component, replacement

L8629 Transmitting coil and cable, integrated, for use with cochlear implant device, replacement


THE FOLLOWING DEVICE IS NOT COVERED BY MEDICARE; THEREFORE, IT IS NOT ELIGIBLE FOR REIMBURSEMENT CONSIDERATION:

V5273 Assistive listening device, for use with cochlear implant




Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

MA11.039d
01/01/2020This policy has been identified for the CPT code update, effective 01/01/2020.

The following narratives have been revised in this policy: 92626, 92627.

MA11.039c
09/25/2019This policy has been reissued in accordance with the Company's annual review process.
08/29/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on Cochlear Implantation.
01/01/2018This policy has undergone a code update. The following changes were made:
The following HCPCS code has been added to this policy:

L8625

The following narratives have been revised in this policy:

L8618; L8624


MA11.039b
02/15/2017The policy has been reviewed and reissued to communicate the Company’s continuing position on Cochlear Implants.
10/01/2016The Company’s coverage position has changed from Experimental/Investigational to Medically Necessary for cochlear implantation with a hybrid cochlear implant/hearing aid device.

MA11.039a
06/22/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on Cochlear Implants.
03/27/2015This policy was expanded to communicate the Company's position of experimental/investigational for cochlear implantation for unilateral hearing loss and with a hybrid cochlear implant/hearing aid device.
  • The following ICD-9 CM code has been removed from this policy: 389.10 Sensorineural hearing loss, unspecified
  • The following ICD-9 CM codes have been added to this policy: 389.05, 389.13, 389.15, 389.17, 389.21, 996.59
  • The following ICD-10 CM codes have been added to this policy: T85.618A, T85.618D, T85.618S, T85.628A, T85.628D, T85.628S, T85.638A, T85.638D, T85.638S, T85.698A, T85.698D, T85.698S, Z45.328, Z45.49, Z46.2, H90.11, H90.12, H90.41, H90.42, H90.71, H90.72
  • The following ICD-10 CM codes have been removed from this policy: H90.5 Unspecified sensorineural hearing loss, Z45.320 Encounter for adjustment and management of bone conduction device
  • The following HCPCS codes have been added to this policy: L8615, L8616, L8617, L8618, L8619, L8621, L8622, L8623, L8624, L8627, L8628, L8629
  • The following CPT code has been added to this policy to represent the NUCLEUS® HYBRID™ L24 COCHLEAR IMPLANT SYSTEM: 69930
  • The following HCPCS code has been added to this policy to represent the NUCLEUS® HYBRID™ L24 COCHLEAR IMPLANT SYSTEM: L8614

MA11.039
01/01/2015This is a new policy.





Version Effective Date: 01/01/2020
Version Issued Date: 01/02/2020
Version Reissued Date: N/A